Diabetic Macular EdemaPhase 1/2NCT00959725
Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
A Phase 1/2 study testing Infliximab (intravitreal, 2.0mg/0.05ml) in people with Diabetic Macular Edema, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Infliximab (intravitreal, 2.0mg/0.05ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years of age or older.
- Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
- Participant must have a negative PPD skin test.
- Participant must understand and sign the protocol's informed consent document.
- Participants must have DME as defined by all of the following criteria:
- Presence of diabetes (type I or type II)
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- Macular edema defined as a central macular thickness of ≥ 250μm on OCT.
- Participant must have visual acuity between 20/40 and hand motions in the study eye.
- Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
- Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.
- If both eyes of a participant qualify for inclusion, then the eye with worse visual acuity will be chosen.
Who cannot join
- Participant is in another investigational study and actively receiving study therapy.
- Participant has proliferative diabetic retinopathy.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
- Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
- Participant is expected to need ocular surgery or panretinal photocoagulation in the study eye during the course of the study.
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- Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
- Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
- Participant has had a pars plana vitrectomy in the study eye.
- Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
- Participant with a history of ocular herpes simplex virus infection in the study eye.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Mount Sinai School of Medicine
New York, New York, 10029
Farzin Forooghian, MD, 212-241-0939 ext. 40939, farzin.forooghian@mssm.edu
Roje-Oktay Kacmaz, MD, 212-824-7645, roje-oktay.kacmaz@mssm.edu
About this study
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.
Read the detailed description
Participants with diabetic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.
- Conditions
- Diabetic Macular Edema
- Being tested
- Infliximab (intravitreal, 2.0mg/0.05ml)
- Keywords
- Infliximab, Diabetes, Macular Edema
- Medical subject headings
- Diabetes Mellitus, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab (intravitreal, 2.0mg/0.05ml)Drug
Also called Remicade™
One injection of intravitreal infliximab (2.0mg/0.05ml).
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal infliximab. | Experimental | Not described Receives: Drug: Infliximab (intravitreal, 2.0mg/0.05ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity
Measured: Three months
Secondary outcomes (1)
Macular thickness
Measured: One, two, and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Investigators
- Farzin Forooghian, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959725
- Sponsor's protocol ID
- GCO # 09-1195
- Status last verified
- Aug 2009
- First submitted
- 14 Aug 2009
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):825-30, 830.e1. doi: 10.1016/j.ajo.2008.12.004. Epub 2009 Feb 10.
PubMed 19211094Theodossiadis PG, Liarakos VS, Sfikakis PP, Charonis A, Agrogiannis G, Kavantzas N, Vergados IA. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009 Feb;247(2):273-81. doi: 10.1007/s00417-008-0967-4. Epub 2008 Nov 4.
PubMed 18982345Giansanti F, Ramazzotti M, Vannozzi L, Rapizzi E, Fiore T, Iaccheri B, Degl' Innocenti D, Moncini D, Menchini U. A pilot study on ocular safety of intravitreal infliximab in a rabbit model. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1151-6. doi: 10.1167/iovs.07-0932.
PubMed 18326743Olson JL, Courtney RJ, Mandava N. Intravitreal infliximab and choroidal neovascularization in an animal model. Arch Ophthalmol. 2007 Sep;125(9):1221-4. doi: 10.1001/archopht.125.9.1221.
PubMed 17846362
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00959725
- Acronym / sponsor ID
- GCO # 09-1195
- Conditions
- Diabetic Macular Edema
- Keywords
- Infliximab, Diabetes, Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to diabetes.
Detailed description
Participants with diabetic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal infliximab. | Experimental | Drug: Infliximab (intravitreal, 2.0mg/0.05ml) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must be 18 years of age or older.
- Participant has DME that is not amenable to treatment with laser photocoagulation or has been refractory to laser photocoagulation.
- Participant must have a negative PPD skin test.
- Participant must understand and sign the protocol's informed consent document.
- Participants must have DME as defined by all of the following criteria:
Key exclusion criteria (12 listed)
- Participant is in another investigational study and actively receiving study therapy.
- Participant has proliferative diabetic retinopathy.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
- Participant has evidence of ocular disease other than DME in either eye that may confound the outcome of the study (e.g., uveitis, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab (intravitreal, 2.0mg/0.05ml)Also: Remicade™One injection of intravitreal infliximab (2.0mg/0.05ml). | Drug | Intravitreal infliximab. |
Primary outcome
Best-corrected visual acuity
Time frame: Three months
1 secondary outcome
Macular thickness
Time frame: One, two, and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
- Background: PubMed 19211094Theodossiadis PG, Liarakos VS, Sfikakis PP, Vergados IA, Theodossiadis GP. Intravitreal administration of the anti-tumor necrosis factor agent infliximab for neovascular age-related macular degeneration. Am J Ophthalmol. 2009 May;147(5):825-30, 830.e1. doi: 10.1016/j.ajo.2008.12.004. Epub 2009 Feb 10.
- Background: PubMed 18982345Theodossiadis PG, Liarakos VS, Sfikakis PP, Charonis A, Agrogiannis G, Kavantzas N, Vergados IA. Intravitreal administration of the anti-TNF monoclonal antibody infliximab in the rabbit. Graefes Arch Clin Exp Ophthalmol. 2009 Feb;247(2):273-81. doi: 10.1007/s00417-008-0967-4. Epub 2008 Nov 4.
- Background: PubMed 18326743Giansanti F, Ramazzotti M, Vannozzi L, Rapizzi E, Fiore T, Iaccheri B, Degl' Innocenti D, Moncini D, Menchini U. A pilot study on ocular safety of intravitreal infliximab in a rabbit model. Invest Ophthalmol Vis Sci. 2008 Mar;49(3):1151-6. doi: 10.1167/iovs.07-0932.
- Background: PubMed 17846362Olson JL, Courtney RJ, Mandava N. Intravitreal infliximab and choroidal neovascularization in an animal model. Arch Ophthalmol. 2007 Sep;125(9):1221-4. doi: 10.1001/archopht.125.9.1221.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzin Forooghian, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infliximab (intravitreal, 2.0mg/0.05ml) in people with Diabetic Macular Edema, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roje-Oktay Kacmaz, MD (212-824-7645, roje-oktay.kacmaz@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959725, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2009.